A survey of knowledge, perceptions and use of core outcome sets among clinical trialists.

BACKGROUND: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists' knowledge, perceptions and experiences of COS. METHODS: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists' familiarity with and understanding of COS, along with experiences of COS use and development. RESULTS: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). CONCLUSIONS: Enhancing clinical trialists' use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS.

Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study: Open science policies of medical journals.

Objectives: To audit the transparent and open science standards of health and medical sciences journal policies and explore the impact of the COVID-19 pandemic. Design: Repeat cross-sectional study. Setting: 19 journals listed in Google Scholar's Top Publications for health and medical sciences. Participants: Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine. Main outcome measures: We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) to evaluate journals standards. Results: TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2-12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4-12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic. Conclusions: The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

Extended use or reuse of single-use surgical masks and filtering face-piece respirators during the coronavirus disease 2019 (COVID-19) pandemic: A rapid systematic review.

BACKGROUND: Shortages of personal protective equipment during the coronavirus disease 2019 (COVID-19) pandemic have led to the extended use or reuse of single-use respirators and surgical masks by frontline healthcare workers. The evidence base underpinning such practices warrants examination. OBJECTIVES: To synthesize current guidance and systematic review evidence on extended use, reuse, or reprocessing of single-use surgical masks or filtering face-piece respirators. DATA SOURCES: We used the World Health Organization, the European Centre for Disease Prevention and Control, the US Centers for Disease Control and Prevention, and Public Health England websites to identify guidance. We used Medline, PubMed, Epistemonikos, Cochrane Database, and preprint servers for systematic reviews. METHODS: Two reviewers conducted screening and data extraction. The quality of included systematic reviews was appraised using AMSTAR-2. Findings were narratively synthesized. RESULTS: In total, 6 guidance documents were identified. Levels of detail and consistency across documents varied. They included 4 high-quality systematic reviews: 3 focused on reprocessing (decontamination) of N95 respirators and 1 focused on reprocessing of surgical masks. Vaporized hydrogen peroxide and ultraviolet germicidal irradiation were highlighted as the most promising reprocessing methods, but evidence on the relative efficacy and safety of different methods was limited. We found no well-established methods for reprocessing respirators at scale. CONCLUSIONS: Evidence on the impact of extended use and reuse of surgical masks and respirators is limited, and gaps and inconsistencies exist in current guidance. Where extended use or reuse is being practiced, healthcare organizations should ensure that policies and systems are in place to ensure these practices are carried out safely and in line with available guidance.

Priority III: top 10 rapid review methodology research priorities identified using a James Lind Alliance Priority Setting Partnership.

OBJECTIVES: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research. STUDY DESIGN AND SETTING: A modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions. RESULTS: Patients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results. CONCLUSION: The results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare.

The Usability and Impact of a Low-Cost Pet Robot for Older Adults and People With Dementia: Qualitative Content Analysis of User Experiences and Perceptions on Consumer Websites.

BACKGROUND: Worldwide, populations are aging exponentially. Older adults and people with dementia are especially at risk of social isolation and loneliness. Social robots, including robotic pets, have had positive impacts on older adults and people with dementia by providing companionship, improving mood, reducing agitation, and facilitating social interaction. Nevertheless, the issue of affordability can hinder technology access. The Joy for All (JfA) robotic pets have showed promise as examples of low-cost alternatives. However, there has been no research that investigated the usability and impact of such low-cost robotic pets based on perceptions and experiences of its use with older adults and people with dementia. OBJECTIVE: The aim of our study was to explore the usability and impact of the JfA robotic cat, as an example of a low-cost robot, based on perceptions and experiences of using the JfA cat for older adults and people with dementia. METHODS: We used a novel methodology of analyzing a large volume of information that was uploaded by reviewers of the JfA cat onto online consumer review sites. Data were collected from 15 consumer websites. This provided a total of 2445 reviews. Next, all reviews were screened. A total of 1327 reviews that contained information about use of the JfA cat for older adults or people with dementia were included for analysis. These were reviews that contained terms relating to "older adults," "dementia," and "institutional care" and were published in the English language. Descriptive statistics was used to characterize available demographic information, and textual data were qualitatively analyzed using inductive content analysis. RESULTS: Most reviews were derived from consumer sites in the United States, and most reviewers were family members of users (ie, older adults and people with dementia). Based on the qualitative content analysis, 5 key themes were generated: prior expectations, perceptions, meaningful activities, impacts, and practicalities. Reviewers had prior expectations of the JfA cat, which included circumstantial reasons that prompted them to purchase this technology. Their perceptions evolved after using the technology, where most reported positive perceptions about their appearance and interactivity. The use of the robot provided opportunities for users to care for it and incorporate it into their routine. Finally, reviewers also shared information about the impacts of device and practicalities related to its use. CONCLUSIONS: This study provides useful knowledge about the usability and impact of a low-cost pet robot, based on experiences and perceptions of its use. These findings can help researchers, robot developers, and clinicians understand the viability of using low-cost robotic pets to benefit older adults and people with dementia. Future research should consider evaluating design preferences for robotic pets, and compare the effects of low-cost robotic pets with other more technologically advanced robotic pets.

Performance and impact of disposable and reusable respirators for healthcare workers during pandemic respiratory disease: a rapid evidence review.

OBJECTIVES: To synthesise evidence concerning the range of filtering respirators suitable for patient care and guide the selection and use of different respirator types. DESIGN: Comparative analysis of international standards for respirators and rapid review of their performance and impact in healthcare. DATA SOURCES: Websites of international standards organisations, Medline and Embase, hand-searching of references and citations. STUDY SELECTION: Studies of healthcare workers (including students) using disposable or reusable respirators with a range of designs. We examined respirator performance, clinician adherence and performance, comfort and impact, and perceptions of use. RESULTS: We included standards from eight authorities across Europe, North and South America, Asia and Australasia and 39 research studies. There were four main findings. First, international standards for respirators apply across workplace settings and are broadly comparable across jurisdictions. Second, effective and safe respirator use depends on proper fitting and fit testing. Third, all respirator types carry a burden to the user of discomfort and interference with communication which may limit their safe use over long periods; studies suggest that they have little impact on specific clinical skills in the short term but there is limited evidence on the impact of prolonged wearing. Finally, some clinical activities, particularly chest compressions, reduce the performance of filtering facepiece respirators. CONCLUSION: A wide range of respirator types and models is available for use in patient care during respiratory pandemics. Careful consideration of performance and impact of respirators is needed to maximise protection of healthcare workers and minimise disruption to care.

A scoping review of research on the determinants of adherence to social distancing measures during the COVID-19 pandemic.

This scoping review focused on answering key questions about the focus, quality and generalisability of the quantitative evidence on the determinants of adherence to social distancing measures in research during the first wave of COVID-19. The review included 84 studies. The majority of included studies were conducted in Western Europe and the USA. Many lacked theoretical input, were at risk for bias, and few were experimental in design. The most commonly coded domains of the TDF in the included studies were 'Environmental Context and Resources' (388 codes across 76 studies), 'Beliefs about Consequences' (34 codes across 21 studies), 'Emotion' (28 codes across 12 studies), and 'Social Influences' (26 codes across 16 studies). The least frequently coded TDF domains included 'Optimism' (not coded), 'Intentions' (coded once), 'Goals' (2 codes across 2 studies), 'Reinforcement' (3 codes across 2 studies), and 'Behavioural Regulation' (3 codes across 3 studies). Examining the focus of the included studies identified a lack of studies on potentially important determinants of adherence such as reinforcement, goal setting and self-monitoring. The quality of the included studies was variable and their generalisablity was threatened by their reliance on convenience samples.

Investigating and evaluating evidence of the behavioural determinants of adherence to social distancing measures - A protocol for a scoping review of COVID-19 research.

Background: The WHO has declared the outbreak of coronavirus disease 2019 (COVID-19) as a pandemic. With no vaccine currently available, using behavioural measures to reduce the spread of the virus within the population is an important tool in mitigating the effects of this pandemic. As such, social distancing measures are being implemented globally and have proven an effective tool in slowing the large-scale spread of the virus. Aim: This scoping review will focus on answering key questions about the state of the evidence on the behavioural determinants of adherence to social distancing measures in research on COVID-19.  Methods: A scoping review will be conducted in accordance with guidelines for best practice. Literature searches will be conducted using online databases and grey literature sources. Databases will include Medline, Web of Science, Embase and PsycInfo, alongside relevant pre-print servers. Grey literature will be searched on Google Scholar. Screening, data extraction and quality appraisal will be conducted by members of the research team, with any discrepancies resolved by consensus discussion. Quality appraisal will be conducted using the Cochrane's ROBINS-I tool, the Cochrane Risk of Bias tool, and the JBI Critical Appraisal Checklist where appropriate. Results will be analysed by mapping findings onto the Theoretical Domains Framework and visualising characteristics of the included studies using EviAtlas. This scoping review is pre-registered with Open Science Framework. Conclusions The results of this study may facilitate the systematic development of behavioural interventions to increase adherence to social distancing measures.

Classification of aerosol-generating procedures: a rapid systematic review.

In the context of covid-19, aerosol generating procedures have been highlighted as requiring a higher grade of personal protective equipment. We investigated how official guidance documents and academic publications have classified procedures in terms of whether or not they are aerosol-generating. We performed a rapid systematic review using preferred reporting items for systematic reviews and meta-analyses standards. Guidelines, policy documents and academic papers published in english or french offering guidance on aerosol-generating procedures were eligible. We systematically searched two medical databases (medline, cochrane central) and one public search engine (google) in march and april 2020. Data on how each procedure was classified by each source were extracted. We determined the level of agreement across different guidelines for each procedure group, in terms of its classification as aerosol generating, possibly aerosol-generating, or nonaerosol-generating. 128 documents met our inclusion criteria; they contained 1248 mentions of procedures that we categorised into 39 procedure groups. Procedures classified as aerosol-generating or possibly aerosol-generating by ≥90% of documents included autopsy, surgery/postmortem procedures with high-speed devices, intubation and extubation procedures, bronchoscopy, sputum induction, manual ventilation, airway suctioning, cardiopulmonary resuscitation, tracheostomy and tracheostomy procedures, non-invasive ventilation, high-flow oxygen therapy, breaking closed ventilation systems, nebulised or aerosol therapy, and high frequency oscillatory ventilation. Disagreements existed between sources on some procedure groups, including oral and dental procedures, upper gastrointestinal endoscopy, thoracic surgery and procedures, and nasopharyngeal and oropharyngeal swabbing. There is sufficient evidence of agreement across different international guidelines to classify certain procedure groups as aerosol generating. However, some clinically relevant procedures received surprisingly little mention in our source documents. To reduce dissent on the remainder, we recommend that (a) clinicians define procedures more clearly and specifically, breaking them down into their constituent components where possible; (b) researchers undertake further studies of aerosolisation during these procedures; and (c) guideline-making and policy-making bodies address a wider range of procedures.

Investigating and evaluating evidence of the behavioural determinants of adherence to social distancing measures - A protocol for a scoping review of COVID-19 research

Background: The WHO has declared the outbreak of coronavirus disease 2019 (COVID-19) as a pandemic. With no vaccine currently available, using behavioural measures to reduce the spread of the virus within the population is an important tool in mitigating the effects of this pandemic. As such, social distancing measures are being implemented globally and have proven an effective tool in slowing the large-scale spread of the virus. Aim: This scoping review will focus on answering key questions about the state of the evidence on the behavioural determinants of adherence to social distancing measures in research on COVID-19.  Methods: A scoping review will be conducted in accordance with guidelines for best practice. Literature searches will be conducted using online databases and grey literature sources. Databases will include Medline, Web of Science, Embase and PsycInfo, alongside relevant pre-print servers. Grey literature will be searched on Google Scholar. Screening, data extraction and quality appraisal will be conducted by members of the research team, with any discrepancies resolved by consensus discussion. Quality appraisal will be conducted using the Cochrane's ROBINS-I tool, the Cochrane Risk of Bias tool, and the JBI Critical Appraisal Checklist where appropriate. Results will be analysed by mapping findings onto the Theoretical Domains Framework and visualising characteristics of the included studies using EviAtlas. This scoping review is pre-registered with Open Science Framework. Conclusions The results of this study may facilitate the systematic development of behavioural interventions to increase adherence to social distancing measures.

Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff.

BACKGROUND: In epidemics of highly infectious diseases, such as Ebola, severe acute respiratory syndrome (SARS), or coronavirus (COVID-19), healthcare workers (HCW) are at much greater risk of infection than the general population, due to their contact with patients' contaminated body fluids. Personal protective equipment (PPE) can reduce the risk by covering exposed body parts. It is unclear which type of PPE protects best, what is the best way to put PPE on (i.e. donning) or to remove PPE (i.e. doffing), and how to train HCWs to use PPE as instructed. OBJECTIVES: To evaluate which type of full-body PPE and which method of donning or doffing PPE have the least risk of contamination or infection for HCW, and which training methods increase compliance with PPE protocols. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and CINAHL to 20 March 2020. SELECTION CRITERIA: We included all controlled studies that evaluated the effect of full-body PPE used by HCW exposed to highly infectious diseases, on the risk of infection, contamination, or noncompliance with protocols. We also included studies that compared the effect of various ways of donning or doffing PPE, and the effects of training on the same outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed the risk of bias in included trials. We conducted random-effects meta-analyses were appropriate. MAIN RESULTS: Earlier versions of this review were published in 2016 and 2019. In this update, we included 24 studies with 2278 participants, of which 14 were randomised controlled trials (RCT), one was a quasi-RCT and nine had a non-randomised design. Eight studies compared types of PPE. Six studies evaluated adapted PPE. Eight studies compared donning and doffing processes and three studies evaluated types of training. Eighteen studies used simulated exposure with fluorescent markers or harmless microbes. In simulation studies, median contamination rates were 25% for the intervention and 67% for the control groups. Evidence for all outcomes is of very low certainty unless otherwise stated because it is based on one or two studies, the indirectness of the evidence in simulation studies and because of risk of bias. Types of PPE The use of a powered, air-purifying respirator with coverall may protect against the risk of contamination better than a N95 mask and gown (risk ratio (RR) 0.27, 95% confidence interval (CI) 0.17 to 0.43) but was more difficult to don (non-compliance: RR 7.5, 95% CI 1.81 to 31.1). In one RCT (59 participants), people with a long gown had less contamination than those with a coverall, and coveralls were more difficult to doff (low-certainty evidence). Gowns may protect better against contamination than aprons (small patches: mean difference (MD) -10.28, 95% CI -14.77 to -5.79). PPE made of more breathable material may lead to a similar number of spots on the trunk (MD 1.60, 95% CI -0.15 to 3.35) compared to more water-repellent material but may have greater user satisfaction (MD -0.46, 95% CI -0.84 to -0.08, scale of 1 to 5). Modified PPE versus standard PPE The following modifications to PPE design may lead to less contamination compared to standard PPE: sealed gown and glove combination (RR 0.27, 95% CI 0.09 to 0.78), a better fitting gown around the neck, wrists and hands (RR 0.08, 95% CI 0.01 to 0.55), a better cover of the gown-wrist interface (RR 0.45, 95% CI 0.26 to 0.78, low-certainty evidence), added tabs to grab to facilitate doffing of masks (RR 0.33, 95% CI 0.14 to 0.80) or gloves (RR 0.22, 95% CI 0.15 to 0.31). Donning and doffing Using Centers for Disease Control and Prevention (CDC) recommendations for doffing may lead to less contamination compared to no guidance (small patches: MD -5.44, 95% CI -7.43 to -3.45). One-step removal of gloves and gown may lead to less bacterial contamination (RR 0.20, 95% CI 0.05 to 0.77) but not to less fluorescent contamination (RR 0.98, 95% CI 0.75 to 1.28) than separate removal. Double-gloving may lead to less viral or bacterial contamination compared to single gloving (RR 0.34, 95% CI 0.17 to 0.66) but not to less fluorescent contamination (RR 0.98, 95% CI 0.75 to 1.28). Additional spoken instruction may lead to fewer errors in doffing (MD -0.9, 95% CI -1.4 to -0.4) and to fewer contamination spots (MD -5, 95% CI -8.08 to -1.92). Extra sanitation of gloves before doffing with quaternary ammonium or bleach may decrease contamination, but not alcohol-based hand rub. Training The use of additional computer simulation may lead to fewer errors in doffing (MD -1.2, 95% CI -1.6 to -0.7). A video lecture on donning PPE may lead to better skills scores (MD 30.70, 95% CI 20.14 to 41.26) than a traditional lecture. Face-to-face instruction may reduce noncompliance with doffing guidance more (odds ratio 0.45, 95% CI 0.21 to 0.98) than providing folders or videos only. AUTHORS' CONCLUSIONS: We found low- to very low-certainty evidence that covering more parts of the body leads to better protection but usually comes at the cost of more difficult donning or doffing and less user comfort, and may therefore even lead to more contamination. More breathable types of PPE may lead to similar contamination but may have greater user satisfaction. Modifications to PPE design, such as tabs to grab, may decrease the risk of contamination. For donning and doffing procedures, following CDC doffing guidance, a one-step glove and gown removal, double-gloving, spoken instructions during doffing, and using glove disinfection may reduce contamination and increase compliance. Face-to-face training in PPE use may reduce errors more than folder-based training. We still need RCTs of training with long-term follow-up. We need simulation studies with more participants to find out which combinations of PPE and which doffing procedure protects best. Consensus on simulation of exposure and assessment of outcome is urgently needed. We also need more real-life evidence. Therefore, the use of PPE of HCW exposed to highly infectious diseases should be registered and the HCW should be prospectively followed for their risk of infection.